quality of life and self-esteem after botox® injections in depressed and non-depressed patients

Conditions: Depression; Quality of Life

Summary: the primary objective of this study is to determine the alterations in quality of life and self-esteem after botox® injections in the glabella in depressed and non-depressed patients. the secondary objective of this study are: * to assess wrinkles improvement * to evaluate depressive symptoms using beck depression inventory before and after botox® injections. * to elucidate that depression is not a contraindication for botulinum toxin injections.

the study consists of two groups: one with diagnosis of depression (diagnostic criteria from dsm-iv-tr and mini international neuropsychiatric interview - brazilian version 5.0) and other without diagnosis of depression. subjects with depression will be part of group 1. they must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist. subjects with no diagnosis of depression will be part of group 2. subjects included in the study will receive injections of 20 u (as minimal dose) to 40 u (as maximum dose) of btx-a (botox®, allergan, usa) diluted in 0.9% saline, according to standard injections of 4u in 5 points of glabellar area as the treatment. four visits will be scheduled. visit 0 (baseline), visit 1 (intervention), visit 2 (4 weeks), visit 3 (8 weeks) visit 4 (12 weeks). the scales for the assessment of depressive symptoms, beck depression inventory (bdi), will be applied at visits 1,2,3,4; whoqol bref will be applied at baseline visit and 4. rosenberg self-esteem scale will be applied in all visits. photographs will be taken as well as the dermatological evaluation of the wrinkles and folds will be assessed using a 4-points validated severity wrinkles scale, and psychiatric evaluation as well, in both groups.

Eligibility criteria:
inclusion criteria: 1. female subjects,aged between 25 to 60 years; 2. subjects diagnosed as having major depression according to the criteria of dsm-iv, mini international neuropsychiatric interview (mini brazilian version 5.0.0); 3. subjects who are being administered a therapeutic dose of an approved, prescribed antidepressant medication (pattern doses of the literature), and have been using mentioned medication at a stable therapeutic dose for at least three months prior to the randomization visit; 4. subjects with mild (1), moderate (2) or severe (3) glabellar frown lines while at rest according the severity wrinkles scales; 5. female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method; 6. subjects who had never received botulinum toxin a previously; 7. subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form; 8. subjects who will be available throughout the duration of the study; 9. subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol; 10. subjects with critical appreciation preserved, attested by their assistant psychiatrist (for group1); 11. subjects who reside with other family members who assume co-responsibility in the study. exclusion criteria: 1. subjects whose medical history and physical examination present clinical pathology, as myasthenia gravis, eaton-lambert syndrome, neoplasm, muscular diseases, motor neuron diseases, systemic autoimmune or neurological diseases; 2. pregnant or women in breastfeeding, or women planning to become pregnant 3. subjects with suicide risk; 4. subjects addicted to alcohol or illegal drugs within the last 6 months; 5. subjects using amino glycoside and penicillamine antibiotics, quinine and ca2+ channel blockers; 6. subjects using medications that, in the opinion of the investigator may cause depression, such as beta-blockers, oral corticosteroids and interferon; 7. subjects who, in the opinion of the investigator, may potentially require psychiatric hospitalization during the course of the study; 8. subjects with inflammation or active infection in the area to be injected; 9. subjects with a history of non-adherence to medical treatment, or who demonstrate unwillingness to adhere to the study protocol; 10. the presence of any additional active dsm-iv axis i diagnosis, or mental retardation; 11. history of psychiatric hospitalization within the past three years.

Keywords: depression botulinum toxin glabella quality of life self-steem